Spinal stabilizing and guiding fixation system

ABSTRACT

A system to stabilize and guide the growth of the spinal column includes an elongated support member having a width and a length and a guiding connector having a bone connecting portion and a guiding portion. The bone connecting portion secures the guiding connector to a vertebrae and the guiding portion has a bearing element with a passageway adapted to receive the elongated support member. The bearing element permits relative sliding movement of the elongated support element in the passageway of the bearing element. The system may further include a bone fixation element has an elongated support member receiving channel, a locking mechanism and a bone anchoring portion. The bone anchoring portion secures the bone fixation element to bone. The locking mechanism secures the elongated support member in the channel. The guiding connector is moveable along the elongated support member to permit and control the growth of the spinal column along a predetermined path.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/096,453 entitled “SPINAL FIXATION SYSTEM”, filed Sep. 12, 2008, thecontents of which is incorporated in its entirety by reference herein.

BACKGROUND OF THE INVENTION

Early onset scoliosis (EOS) is a pathology that begins affectingchildren generally under the age of ten (10) years. Without treatment, ascoliotic spine can increase its curvature progressively, leading tosevere deformation of the thorax and associated organs. Generally, twosurgical options exist. The first is fusion of the scoliotic spine,which stops growth of the thorax at an early age. The second istreatment of the spine by some form of growth-guiding implants thatgenerally must be adjusted or replaced many times over the course of thepatient's childhood. Usually these further adjustments and replacementsrequire additional surgical operations.

It is desirable to develop an implantation system and method of use thatwill stabilize and control the growth of the spine, and treat spinaldefects such as EOS, which is easy to use.

SUMMARY OF THE INVENTION

The present invention relates to an implant system, more specifically animplant system and guiding connector for treating, repairing orstabilizing a defective or damaged spinal column, more specifically fortreating early onset scoliosis (EOS).

The implant system preferably stabilizes the spinal column and directs,controls and guides the growth of the spinal column along apredetermined path. The system preferably includes one or more elongatedsupport members, typically one or more spinal rods, that are implantedin a desirable position and which direct the growth of the spinal columnby permitting the vertebrae of the spine to grow, but confine andcontrol that growth in a particular direction and path. The systempreferably further includes one or more fixed bone anchors that arefirmly secured to the elongated support members, and are firmly securedto the vertebrae, and one or more guiding connectors that are firmlysecured to the vertebrae but which can slide along the spinal rods. Thefixed bone anchors act as anchor points for the spinal rods whichpreferably act as guiding rails or guiding rods. The guiding connectorsare permitted to move relative to the rods and are guided by the rods todirect the growth of the spine. The guiding (or gliding) connectorsenable passive growth and lengthening of the spine.

In one embodiment, the system to stabilize and guide the growth of thespinal column includes (i) one or more elongated support members,preferably longitudinal spinal rods, having a width and a length; (ii)one or more guiding connectors having a bone connecting portion and aguiding portion, the bone connecting portion configured and adapted tofirmly secure the guiding connector to a vertebrae and the guidingportion having a bearing element having one or more passagewaysconfigured and adapted to receive the elongated support members, whereinthe bearing element permits relative sliding movement of the elongatedsupport members in the passageways of the bearing element; and (iii) oneor more bone fixation elements having an elongated support memberreceiving channel, a locking mechanism and a bone anchoring portion, thebone anchoring portion configured and adapted to firmly secure the bonefixation elements to bone to provide a firm anchoring point, and thelocking mechanism configured and adapted to firmly secure the elongatedsupport member in the channel. The guiding connectors are configured tobe moveable along the elongated support members preferably to permit andcontrol the growth of the spinal column along a predetermined path.

The bone connecting portion of the guiding connector and the boneanchoring portion of the bone fixation element preferably may be one ofthe group of hooks, pins, tacks, stakes, nails, blades, screws andclamps. The bone connecting portion and bone anchoring portion may bemonoaxial, monorotational or polyaxially rotatable with respect to otherportion of the guiding connector or bone fixation element.

In one embodiment the guiding portion of the guiding connector has afront face, a back face, sides, two or more passageways extendingthrough the bearing element from the front face to the back face, and ahousing surrounding the sides of the bearing element and connecting thebearing element to the bone connecting portion, wherein an interiorsurface defines the passageways and preferably is formed of a polymermaterial. In another embodiment, the guiding connector includes aplatform member, one or more bushings, a clamp member and a securingmechanism, wherein the bushings have the passageway and has an outerside surface, the platform member and clamp member substantiallysurrounds the side surface of the bushings, and the securing mechanismhas an unlocked position that permits the bushings to polyaxially rotatewith respect to the platform member and the clamp member and a lockedposition which fixes the position of the bushings with respect to theplatform member and the clamp member. The guiding connector preferablyhas two bushings, each bushing having a frusto-spherical outer surfaceand the securing mechanism comprises a threaded set screw.

In yet another embodiment the bone connecting portion includes a postand the guiding portion includes one or more sleeve connectors, eachsleeve connector having a hollow sleeve defining a bore and a recess forreceipt of the post, whereby the sleeve connector is fitted over thepost. A bushing forming the bearing element preferably is positionedwithin the bore of the sleeve and polyaxially rotatable with respect tothe sleeve, and a nut configured to fit onto and mate with threads onthe post connects and fixes the position of the sleeve connector and thebushing. The elongated support element is preferably slideable withinthe passageway of the bearing element when the bearing element is fixedwith respect to the sleeve by the nut. The sleeve connector may be aC-shaped clamp having a first leg and a second leg, and wherein the nutcompresses the first leg into the second leg to fix the position of thebushing relative to the sleeve while permitting the rod to sliderelative to the bushing. The bushing preferably is formed from a polymermaterial and the sleeve is preferably formed of a material differentthan the bushing.

In a further embodiment the guiding connector includes a housing memberhaving one or more openings which receives one or more bushing and achannel extending through the housing member at an angle relative to theopening, the bushings have the passageway for receiving the elongatedsupport member and the elongated support member is slideable within thebushing when the guiding connector is implanted. A cable preferablyextends from the bone connecting portion and through the channel in thehousing and a crimp secures to the cable to connect the housing memberto the bone connecting portion. In a still further embodiment theguiding portion further includes a platform member and one or morebushings, the bushings mounted on the platform member. A cable memberhaving first and second ends extends at least partially around thebushings and secures the bushings on the platform member and to the boneconnecting portion. The guiding portion may further include a stopmember wherein the cable extends out of the stop member and wraps aroundat least a portion of the bushing and the cable is adjustably fixedlysecurable to the stop member to adjust the tension in the cable.

The guiding connector in one embodiment has a transverse opening in thebone connecting portion and the guiding portion further includes aplatform member having one or more flexible wings having an innersurface and an outer surface, and a connecting portion for attaching theplatform member to the bone connecting portion, wherein the wings arebendable around the elongated support members to form at least a portionof the bearing element, and wherein the guiding connector further has acable, wherein the cable is configured to extend around the outersurface of the wings and through the opening to secure the elongatedsupport members in the bearing element formed by the wings. Preferablythe connecting portion pivotally attaches the platform member to thebone connecting portion. The platform member preferably has a protrusionmember and at least two bendable wings wherein the protrusion member andwings form at least two bays for receipt of two elongated supportmembers, the protrusion and wings constituting at least a portion of thebearing element for the elongated support members.

The system may further include instruments for use with the implants,such as, for example, a guiding connector holder. The guiding connectorholder may include a distal holder having a channel, a proximal holderhaving a channel, and a handle portion having a shaft having a distalend and a proximal end, the proximal end having a stop member. Thechannel of the proximal holder is insertable over the distal end of thehandle portion and slideable relative to the shaft and is configurableto secure the cable tie to the handle portion, and the channel of thedistal holder is insertable over the distal end of the handle portionand slideable relative to the shaft and is configurable to secure thewings, platform member or housing of the guiding connector and cable tieto the handle portion.

The system may also include further implants such as a lateral rodconnecting member having the guiding portion integrally andmonolithically formed with the lateral rod connecting portion, whereinthe lateral rod connecting member is adjustably securable to the boneconnecting portion to adjust the position of the guiding portion and theelongated members with respect to the spinal column. Another implant maybe a lateral offset connector and cable, wherein the bone connectingportion has an opening to receive the cable, the lateral offsetconnector forms the guiding portion and has a port for receiving thecable and two passageways forming the bearing element for receiving theelongated support members, wherein the cable connects the lateral offsetconnector to the bone connecting portion and the cable may be tensionedto adjust the position of the guiding portion and the elongated supportelements relative to the bone connecting portion.

Other implants useable with the system include parallel connectors. Inone embodiment, the parallel connector has a housing comprising a hookfor securely and optionally fixedly receiving at least one of theelongated support members, and an opening for receiving a bushing, thebushing having a bore for slideably receiving the elongated supportmember and permitting in-situ movement of that elongated support member.In another embodiment, the parallel connector has a housing having twobores, two opening, and exterior sides, each opening extending from anexterior side of the housing into the interior of the bores, the boressized to slideably receive the elongated support members and theopenings sized smaller than the width of the elongated support member tosecure the elongated support member within the bores, the housing beingflexible to permit the elongated support member to pass through theopening and into the bores, the housing further having a channel in theexterior side and extending around at least a portion of the bores forreceiving a cable, whereby the cable is receivable in the channel tosecure the elongated support members within the bores and permit slidingmotion of the elongated support members with respect to the housing.

DETAILED DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the application, will be better understoodwhen read in conjunction with the appended drawings. For purposes ofillustrating the preferred implant system and method of use of thepresent invention, drawings of the preferred embodiments are shown. Itshould be understood, however, that the application is not limited tothe precise arrangements, structures, features, embodiments, aspects,methods, and instrumentalities shown, and the arrangements, structures,features, embodiments, aspects, methods and instrumentalities shown maybe used singularly or in combination with other arrangements,structures, features, embodiments, aspects, methods andinstrumentalities. In the drawings:

FIG. 1 is a top plan view of a spinal stabilization and guiding systemof the present invention for directing the growth of a spinal columnalong a predetermined path implanted in the spinal column of a patientin accordance with a first attachment configuration;

FIG. 2 is a perspective view of a first preferred embodiment of aguiding connector in accordance with the present invention that may beused in the stabilization system of FIG. 1;

FIG. 3 is a top plan view of a schematic representation of a spinalstabilization and guiding system of the present invention using aguiding connector in accordance with a second attachment configuration;

FIG. 4 is a top plan view of a schematic representation of a spinalstabilization and guiding system of the present invention using aguiding connector in accordance with a third preferred attachmentconfiguration;

FIG. 5 is a side view of a second preferred embodiment of a guidingconnector in accordance with the present invention;

FIG. 6 is a side perspective, exploded view of the guiding connector ofFIG. 5;

FIG. 7 is a side view of a third preferred embodiment of a guidingconnector in accordance with the present invention;

FIG. 8 is a side perspective, exploded view of the guiding connector ofFIG. 7;

FIG. 9A is a side perspective exploded view of a fourth preferredembodiment of a guiding connector in accordance with the presentinvention;

FIG. 9B is a side perspective view of the guiding connector of FIG. 9Aconnected to a vertebrae in the spine as part of a spinal stabilizationand guiding system;

FIG. 10A is a side perspective view of a fifth preferred embodiment of aguiding connector in accordance with the present invention;

FIG. 10B is a side perspective view of part of a spinal stabilizationand guiding system utilizing the guiding connector of FIG. 10A;

FIG. 10C is a cross-sectional view of the guiding connector of FIG. 10Ataken along line 10C-10C;

FIG. 11 is a side view of a sixth preferred embodiment of a guidingconnector in accordance with the present invention;

FIG. 12A is a side perspective view of a seventh preferred embodiment ofa guiding connector in accordance with the present invention;

FIG. 12B is the bone connecting portion of the guiding connector of FIG.12A;

FIG. 12C is the guiding portion of the guiding connector of FIG. 12A;

FIG. 12D is a side perspective view of the guiding connector of FIG. 12Apreassembled with the bone connecting portion connected to the guidingportion prior to insertion of the spinal rods;

FIG. 13A is a side perspective view of an eighth preferred embodiment ofthe guiding connector in accordance with the present invention;

FIG. 13B is a side perspective view of an alternative design of theguiding connector of FIG. 13A;

FIG. 13C is a side view the guiding connector of FIG. 13A with apreassembled cable tie.

FIG. 13D is a top view of the guiding connector of FIG. 13Bschematically connected to vertebrae according to one method as part ofa spinal stabilization and guiding system;

FIG. 14 is a perspective view of the guiding connector of FIG. 13C andcable tie assembly preassembled to an implant holder;

FIG. 15 represents the component parts of the guiding connector and theimplant holder of FIG. 14;

FIGS. 16A-C represents the steps of assembling the guiding connector andimplant holder instrument into a screwdriver;

FIG. 17 is a top view of an ninth embodiment of a guiding connector inaccordance with the present invention;

FIG. 18 is a perspective view of the bone connecting portion of theguiding connector of FIG. 17;

FIG. 19 is a perspective partial view of the guiding portion of theguiding connector of FIG. 17;

FIG. 20 is a perspective view of a tenth embodiment of a guidingconnector in accordance with the present invention;

FIG. 21 is a perspective view of an eleventh embodiment of a guidingconnector in accordance with the present invention configured as alateral offset connector;

FIG. 22 is a perspective view of the guiding connector of FIG. 21arranged differently in a stabilization and guiding system of thepresent invention;

FIG. 23 is a perspective view of a twelfth embodiment of a guidingconnector in accordance with the present invention configured as aparallel connector; and

FIG. 24 is a perspective view of a thirteenth embodiment of a guidingconnector in accordance with the present invention also configured as aparallel connector.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower”, “upper”,“below”, “above”, “top”, and “bottom” designate directions in thedrawings to which reference is made. The words “inwardly” or “distally”and “outwardly” or “proximally” refer to directions toward and awayfrom, respectively, the geometric center of the spinal stabilizingdevice, system or the surgeon and are not meant to be limited. Thewords, “anterior”, “posterior”, “superior”, “inferior” “lateral” and“medial” and related words and/or phrases designate preferred positionsand orientations in the human body to which reference is made and arenot meant to be limiting. The terminology includes the above-listedwords, derivatives thereof and words of similar import.

Certain preferred embodiments of the invention will now be describedwith reference to the drawings. In general such embodiments relate topreferred spine stabilization and growth guiding systems includingpreferred guiding connectors and related instruments by way ofnon-limiting example for use in the treatment of the spine.

Referring to FIGS. 1-4, a first preferred embodiment of a spinestabilizing and guiding system 100 is shown implanted in the spinalcolumn 7 according to three different attachment configurations. Thespine stabilization system 100 is preferably used in the spine, and maybe used in the cervical, thoracic and/or lumbar regions of the spine.The spinal stabilization system 100 may have particular application inthe correction of early onset scoliosis. While the system 100 isdescribed as generally for use in the spine, it will be appreciated thatthe system 100 may have other uses and may be used as a bone fixation orstabilization system and device for use on other bones or joints, suchas, for example, the shoulder, elbow, wrist, hand, finger, cranium,mandible, ribs, hip, knee, ankle, foot, toe, extremities, and may beused in non-orthopedic and/or non-medical applications.

The spinal stabilization system 100 may include (1) one or moreelongated support elements 9, such as, for example, longitudinal spinalrods 10, (2) one or more standard vertebral fixation devices 15 forsecurely connecting a vertebra to the elongated support elements, suchas, for example, pedicle screws (monoaxial, monorotational, polyaxialscrews), lamina and pedicle hooks (monoaxial, monorotational, and/orpolyaxial hooks), or other bone anchors which may be firmly secured toone or more vertebrae preferably to act as anchor points, (3) one ormore guiding connectors for anchoring in vertebra and for guiding andcontrolling the movement of the vertebrae along the elongated supportelements 9 so that the vertebra of the spinal column 7 may move along agrowth path to permit growth of the spinal column 7 and thorax, (4) oneor more lateral connectors for laterally offsetting the guidingconnectors from the axis of the spine; and (5) one or more parallelconnectors for permitting relative motion of elongated support members.

It should be understood that the elongated support element 9 istypically a spinal rod 10 but that the system is not limited to use withspinal rods and any elongated support member of any shape andconfiguration is contemplated. The support member 9 may include solid,non-solid, hollow, partially solid, flexible or dynamic spinal rods 10.The spinal rods 10 for use in the stabilization system 100 may bestandard spinal rods commonly used in spinal stabilization surgeries,generally of approximately 6 mm in diameter, although it may bepreferred for pediatric uses, to which the present system mayparticularly be adapted and designed, to utilize 5.5 mm spinal rods.Alternatively or additionally, the system may utilize dynamic spinalrods which may permit flexing of the spinal rod 10 implanted within apatient.

The elongated support members 9, referred to herein interchangeably asspinal rods, are utilized to act as guide rails to direct the growth ofthe spine. That is, in one preferred embodiment, the surgeon implantsthe spinal rods so that they are configured to correspond to a desiredgrowth path for a patient. The spinal rods are preferably fixedlysecured to one or more vertebrae which act as anchor points. The spinalrod is implanted to correspond to the desired growth path for the spineby supplying or bending the spinal rod to a desired configuration.Guiding connectors are then preferably connected to other vertebrae andare permitted to move and slide along the spinal rods to enable passivegrowth and lengthening of the spine. The spinal rods act as rails whichdirect and control the motion of the guiding connectors and thus controlthe direction of growth of the vertebrae to which they are attached. Thefixed anchor points for the stabilizing and guiding system may belocated at the ends or in the middle of the construct.

It will be appreciated that the bone anchors and/or guiding connectorsmay be connected to the vertebrae by polyaxial, monoaxial, ormonorotational screws, hooks, pins, tacks, nails, stakes, blades orother types of bone anchor mechanisms, or clamps. The system mayoptionally include one or more transconnectors 12 for attaching twoparallel spinal rods 10, 10′ implanted in the spinal column 7 of apatient.

Referring to FIG. 1, a first preferred spinal stabilization system 100and attachment configuration includes a first pair of elongated supportmembers 9, typically spinal rods 10, longitudinally placed on theposterior spine on either or both sides of the spinous process 8 of aspinal column 7. Rods 10, 10′, 10″, 10′″ are fixedly attached tovertebra by bone fixation elements 15, e.g., standard pedicle screws 15.The body portion of the standard pedicle screw typically has arod-receiving channel and receives a locking cap or mechanism to securethe spinal rod 10, 10′ to the pedicle screw 15. A pedicle screw useablein the spinal fixation system 100 is disclosed in International PatentAppln. No. PCT/US2008/070670, entitled “Polyaxial Bone FixationElement”, filed Jul. 21, 2008, the entire contents of which areincorporated by reference herein. The bone fixation element 15 may havea body portion that is pivotal with respect to the bone anchor, commonlyknown as polyaxial pedicle screws or polyaxial hooks. Monoaxial ormonorotational screws and/or hooks are also contemplated for use withthe spinal stabilization and guiding system 100. Other bone fixationelements are also contemplated for use with the stabilization andguiding system 100.

As shown in FIG. 1, the system 100 may be anchored at superior vertebrae1, 2 and inferior vertebrae 5, 6 via standard pedicle screws 15 whichsecure the spinal rods 10, 10′, 10″, 10″ in a fixed position relative tothe attached vertebrae. In the example shown in FIG. 1, four (4)standard pedicle screws 15 are implanted in vertebrae 1 and 2, and four(4) standard pedicle screws 15 are implanted in vertebrae 5, 6. Twospinal rods 10, 10′ extend substantially parallel from the superiorvertebra 1, 2 toward the inferior vertebrae 5, 6, and two spinal rods10″, 10′″ extend substantially parallel from the inferior vertebra 5, 6toward the superior vertebrae 1, 2 so that in total four (4) spinal rodsare utilized. The two spinal rods 10, 10′ that extend from the superiorvertebra 1, 2 traverse the two intermediate vertebrae 3, 4, while thetwo spinal rods 10″, 10′″ that extend from inferior vertebrae 5, 6 alsotraverse the two intermediate vertebrae 3,4 so that all four (4) rods 20preferably extend over at least a portion of the intermediate vertebrae3, 4. The four (4) rods 10, 10′, 10″, 10′″ preferably are substantiallyparallel and provide for telescopic extension of the system and permitgrowth of the spine and relative movement of the vertebra 2, 3, 4, 5.The construct of FIG. 1 is referred to as a parallel construct. Theparallel construct is anchored distally and proximally and in the middletelescopic elongation is permitted by guiding connectors 20.

Gliding or guiding connectors 20 are attached to the intermediatevertebrae 3, 4. Guiding connectors 20 preferably permit growth andlengthening of the spine. In particular, the spacing between theadjacent vertebrae can change as the patient grows as the spinal rods10, 10′, 10″, 10′″ can slide and telescope with respect to the guidingconnector 20.

The guiding connector 20 preferably should be firmly secured to one ormore vertebrae so the guiding connectors can slide and glide withrespect to the spinal rods as the spinal column grows. Guiding connector20 preferably includes a bone connecting portion 30 and a rod guidingportion 40. In the embodiment of FIG. 2, the bone connecting portion 30is a screw 35 having a screw shaft portion 37 having a longitudinal axis39. While bone connecting portion is illustrated and described as ascrew 35 in the preferred embodiment of FIG. 2, it will be appreciatedthat the bone connecting portion 30 may include polyaxial, monoaxial ormonorotational screws, hooks, pins, blades, stakes, nails, clamps, orother types of bone anchoring mechanisms now known or later discovered.

The guiding portion 40 of the guiding screw 35 includes at least onebearing element 50 having one or more passageways. The guiding portion40 of the embodiment of FIG. 2 preferably has two (2) passageways 42, 44that are inclined at an angle, preferably generally perpendicular, tolongitudinal axis 39 of the shaft 37 of the screw 35. Passageways 42, 44extend through the guiding portion 40 to enable the spinal rods to beinserted there through. Passageways 42, 44 are sized and dimensioned topermit sliding movement of the spinal rods through the guiding portion40 when the system is implanted in a patient. In this manner,passageways 42, 44 preferably have a diameter PD that is close to thediameter RD of the spinal rods 10, 10′, 10″, 10′″ and preferably 42, 44serve as a bearing sleeve. The larger the width W of the passageways(e.g., the greater the length of the bearing sleeve), potentially theeasier the rod may slide and move in the passageway. Exemplary widths Wof the bearing element 50 are about 1 mm to about 10 mm. Otherdimensions for the width W of the bearing element 50 are contemplatedand will depend upon a variety of factors.

Alternatively, the guiding portion 40 may have two passageways 42, 44that that extend substantially perpendicular to the longitudinal axis ofthe shaft 37 but are open at the top portion to form a channel 55, 57which communicates with the bores 52, 54. The channel 55, 57 enables asurgeon to snap in the spinal rods 10, 10′ from the top of the guidingconnector 20 to facilitate ease of assembly of the system 100 (see FIG.24). The channels 55, 57 are preferably less than the width or diameterRD of the spinal rod 10 so that the spinal rod 10 is constrained by theguiding portion 40 and is not easily detachable from the guidingconnector 20. After the spinal rod is placed in passageways 42, 44,member 58 or cable or cable tie 62 may close the channels 55, 57 toprevent the spinal rod 10 from being dislodged from the guiding portion40 when implanted in the patient.

The materials of construction for the guiding portion 40, andspecifically the bearing element 50 are preferably chosen to minimizefriction and wear between the interior surface 43, 45 forming thepassageways 42, 44 and the spinal rods 10, 10′, 10″, 10′″. The materialforming the passageways 42, 44 or at least the surface 43, 45 whichinteracts with and contacts the rods 10, 10′, 10″, 10′″ may be formedfrom PEEK, or ultra high molecular weight polyethylene (UHMWPE). The rodand/or bone connecting portion 30 may preferably be formed of metalssuch as, for example, titanium, titanium alloys (Ti-6Al-7Nb), stainlesssteel, cobalt chromium, Nitinol, etc. The spinal rods and/or interiorsurface 43, 45 of the passageways 42, 44 may be polished or coated, suchas with polytetrafluoroethylene for example, to reduce the coefficientof friction to enhance the gliding and/or sliding characteristics of thespinal rods 20 through the passageways 42, 44.

The guiding portion 40 may include a housing 65 that at least partiallysurrounds, and may preferably completely surround the sides of thebearing element 50 preferably to provide support and strength to thebearing element 50. The housing 65 may be connected to the boneconnecting portion 35. The housing 65 may be connected to the boneconnecting portion 35 in a variety of manners including, but not limitedto, bonding, welding, gluing, press fit, threading connection, integraland monolithic, etc. The housing may be formed of a biocompatible metalor metal alloy or other materials. The passageways 42, 44 and thebearing element 50 preferably are fixed with respect to the housing 65and the bone connecting portion such that the pathway for the spinal rodis not adjustable before, during or after implantation of the guidingconnector 20.

In the stabilization and guiding system 100, the spinal rod 10 can slidewithin the passageway 42 located in the guided connector 20 implanted invertebrae 3, and slide through the passageway 42 of the guidingconnector 20 implanted in vertebrae 4, as a result of vertebrae 2 movingrelative to vertebrae 3 and 4 (or vertebrae 3 moving relative tovertebrae 4). Additionally, the spinal rod 10′ preferably is permittedto move and slide in passageway 44 of the guiding connector 20 implantedin vertebrae 3 and the passageway of guiding connector 20 implanted invertebrae 4 as a result of vertebrae 2 moving relative to vertebrae 3and 4 (or vertebrae 3 moving relative to vertebrae 4). The spinal rod10″ is permitted to move and slide within passageway 44 of the guidingconnector 20 implanted in vertebrae 3, and within the passageway 44 ofthe guiding connector 20 implanted in vertebrae 4 as a result ofvertebrae 5 moving relative to vertebrae 3 and 4 (or vertebrae 3 movingrelative to vertebrae 4). Additionally, spinal rod 10′″ preferably ispermitted to move and slide within passageway 44 of the guidingconnector 20 implanted in vertebrae 3 and passageway 44 of the guidingconnector 20 implanted in vertebrae 4 as a result of vertebrae 5 movingrelative to vertebrae 3 and 4 (or vertebrae 3 moving relative tovertebrae 4). Thus, the system permits the vertebrae, which areconnected to the guiding connectors, to move along a path defined by theshape and configuration of the implanted spinal rods.

The guiding portion 40 is designed and configured to move along thespinal rods which preferably constrain and restrict the movement of theguiding connectors in a particular path and/or direction. Since theguiding connector is attached, preferably firmly attached, to thevertebrae, the growth and movement of the vertebrae and the growth ofthe spine is permitted, but preferably is constrained and limited to thepath permitted and defined by the implanted spinal rods. The spinal rods10, standard fixation devices 15 (e.g., pedicle screws) and guidingconnectors 20 can be configured in the spinal column 7 in variousconfigurations, such as, for example, the configuration of FIG. 1 wherethe standard fixed pedicle screws 15 which anchor and fix the spinalrods 10, 10′, 10″, 10′″ with respect to the vertebrae are located andconnected to the vertebrae at the ends of the implanted system 100 whilethe guiding connectors 30 are connected to the intermediate vertebrae 3,4 located between the fixed end vertebrae.

While the system 100 has been shown as having fixed bone anchors 15 intwo adjacent vertebrae at the ends of the implanted system, the fixedbone anchors 15 can be attached to a single vertebrae using one or morepairs of fixed bone anchors 15, and/or the fixed bone anchors can spanone or more vertebrae. In addition, while system 100 in FIG. 1 has beenillustrated and described as being implanted laterally on both sides ofthe spinous process 8, it is contemplated that the system may beutilized either on the right lateral side or the left lateral side ofthe spinous process 8.

Referring to FIG. 3, another configuration of the stabilizing andguiding system 100′ is shown where in this case the standard pediclescrews 15 are fixed to the intermediate vertebrae 3, 4, while theguiding connectors 20 are attached to the end vertebrae 2, 5. Morespecifically, two standard pedicle screws 16, 17 are fixed tointermediate vertebrae 3 while two standard pedicle screws 18, 19 areattached to adjacent vertebrae 4. A first spinal rod 10 is fixedlyconnected to pedicle screws 16, 18 while a second spinal rod 10′ isfixedly connected to standard pedicle screw 18, 19. Spinal rods 10, 10′preferably are curved and correspond to the appropriate spinal curvaturefor a healthy normal spinal section and assists in defining the path ofgrowth for the spinal vertebrae.

Guiding connectors 20 are connected to the first vertebrae 2 and thelast vertebrae 5. The guiding connectors 20 are preferably in the formof screws 35, having a guiding portion 40 as shown in FIG. 2 but may beany of the embodiments described and illustrated herein andmodifications thereof. The bearing element 50 of the guiding portion 40may have a plurality of passageways 42, 44 for receiving spinal rods 10,10′, or each end vertebrae 2, 5 may include one or more guidingconnectors 20 each having a bear element 50 which contains only a singlepassageway 42 for receiving a single spinal rod.

The system and construct 100′ of FIG. 3 preferably fixes the apex of ascoliotic curve. The term “apex”, as used herein denotes the center ofcurvature of a scoliotic deformity and lies in the middle of the curve.The apex preferably would include the origin of the pathology, andtreating it actively preferably means focusing on the cause ofdeformation. By fixing the apex, the center of the curvature wouldbecome fused and immobile. The end vertebrae 2 and 5, however, would beable to move relative to the intermediate vertebrae 3, 4 and the system100′ would direct the path of that movement along the direction andcurvature of the spinal rods 10, 10′.

In another configuration of stabilizing and guiding system 100″ asillustrated in FIG. 4, the system 100″ uses standard pedicle screws 15in end vertebrae 2 to fix the spinal rod 10, 10′ with respect to thevertebrae 2 at only one end of the construct/system. The system andconstruct 100″ of FIG. 4 is intended to fix the curvature of the spinalcolumn 7 at the end (vertebrae 2) and permit spinal growth away from thevertebrae 2. Specifically the system 100″ of FIG. 4 includes spinal rods10, 10′ connected to standard pedicle screws 15 fixed in vertebrae 2.Spinal rods 10, 10′ extend through guiding connectors 20 secured tovertebrae 3, 4 and 5. The spinal rods 10, 10′ extend through thepassageways 42, 44 located within the bearing element 50 of the guidingportion 40 of the guiding connectors 20. The guiding connectors 20 arepermitted to move along the spinal rods 10, 10′ to permit and enablepassive growth and lengthening of the spine preferably along apredetermined path defined by the spinal rods 10, 10′.

Referring to FIGS. 5 and 6, a second preferred embodiment of a guidingconnector 120 is shown. The guiding connector 120 preferably comprises abone connecting portion 130 and a guiding portion 140. The boneconnecting portion 130 is preferably in the form of a bone screw 135.Alternatively, however, the bone connecting portion 130 may be, forexample, a hook, pin, blade, nail, tack, stake or other fasteners, suchas, for example, a clamp, an implant, etc.

The guiding portion 140 preferably comprises platform member 152, one ormore bushings 150, a clamp member 160, and a set screw 170. In theembodiment of FIGS. 5 and 6, the guiding connector 130 includes two (2)bushings 153, 154 although embodiments with only one bushing 150 or morethan two bushings 150 are contemplated. The guiding connector 130preferably incorporates one or more bushings 150 that preferably have afrusto-spherical outer surface 151 that preferably moves and adjustsangularly within the platform member 152 and the clamp member 160 topermit polyaxial movement of the bushing 150 relative to the platformmember 152. The bushings 150 preferably have a bore 142 sized to permitthe spinal rod 10 to be inserted through and slide with respect to theguiding portion 140. The material of the inner surface 141 of the bore142 preferably is formed of a material chosen to minimize friction andwear between the bushing 150 and the spinal rods 10, 10′, 10″, 10″.Preferred materials for the bushing 150 include polymers such as PEEKand ultra high molecular weight polyethylene (UHMWPE). Preferredmaterials for the spinal rods 10, 10′, 10″, 10″ include titanium alloy(TI-6AL-6NB), cobalt chromium, stainless steel, or other materials. Thebushings 150 can be reinforced with biocompatible metals or otherbiocompatible materials.

The bushings 153, 154 can be preassembled and connected to the clampmember 160. The clamp member 160 can then be positioned with respect tothe platform member 152 and thereafter connected together with the setscrew 170. The guiding connector 120 of FIGS. 5 and 6 permits thesurgeon to slide the bushings 150 over the spinal rods and then positionthe rods and bushing members on the platform member 152 which may beintegral with the bone connecting portion 130 of the guiding connector120. The bushing 150 preferably is permitted to rotate along the X, Y,and Z axis plus translate or slide along the spinal rod.

Surgeons often bend spinal rods and create a desired rod shape in orderto better fit the patient's spine or create the desired curvature forthe patient's spinal column. The adjustability of the bushing 150 withrespect to the guiding connector 120 provides increased flexibility.Once the desired orientation and position of the bushing 150 is set, thedoctor can tighten the set screw 170 to position the bushing 150 inplace on the platform member 152. The guiding connectors 120 can be usedin the systems and constructs described in FIGS. 1 and 3, 4 to directthe growth of the spinal column 7 along a desired growth path.

Referring to FIGS. 7 and 8, a third preferred guiding connector 120′with moveable bushings 150′ is illustrated. The guiding connector 120′of FIGS. 7 and 8 include a bone connecting portion 130′ and a guidingportion 140′. The guiding portion 140′ may include one or more sleeveconnectors 175, one or more bushings 150′ and a nut 185. The embodimentof FIGS. 7 and 8 illustrates using two sleeve connectors 175. Eachsleeve connector 175 may include a sleeve 176 defining a bore 177 forreceiving the bushing 150′. The sleeve connector 175 further includes arecess 178 for receipt of the bone connecting portion 130′. The sleeveconnectors 175 are placed over the bone connecting portion 130′ byplacing the post 132 up through the recess 178. The sleeve connectors175 are adjustable on the post 132 so that the bores 177 may be parallelor oriented at angles relative to one another. The nut 185 can lock theposition of the sleeve connectors 175 on the bone connecting portion atdesirable relative angles.

The bushing 150′ can be configured and arranged similar to the bushings150 and may have an exterior surface that preferably isfrusto-spherically shaped and able to pivot, rotate and articulate withrespect to the sleeve 176. The bushing 150′ also preferably contains abore 142′ for receiving the spinal rods 10. The spinal rods 10 areconfigured to slide and glide with respect to the bushing 150′ in-situ.After the angular orientation and position of the bushings 150′ areadjusted, a surgeon can fix the position of the bushing 150′ bytightening the nut 185 on the top of the shaft 137. The post 132preferably has screw threads to mate with screw threads on the nut 185.After the nut 185 is tightened, the position and orientation of thesleeve connectors 177 and the bushings 150′ is preferably fixed whilestill permitting the spinal rods 10 to slide and glide through thebushing 150′.

In an alternative embodiment, the sleeve connector 175 can be formed asa C-clamp having two legs extending there from which are compressedtogether in order to clamp the position of the bushing 150′ with respectto the sleeve connector 175. When the nut 185 is tightened the first legof the sleeve connector 175 is compressed into the second leg of thesleeve connector 175 making the bore 177 of the sleeve 176 smaller, thusclamping the position and orientation of the bushing 150′ in the sleeve176.

Referring to FIGS. 9A-9B, a fourth preferred embodiment of a guidingconnector 120″ for use in a spinal stabilization and guiding system isshown. The guiding connector 120″ includes bone connecting portion 130″,preferably in the form of a pedicle screw shaft 137″ that is cannulated,and a guiding portion 140″. The guiding portion 140″ includes a housingmember 165″ having openings for one or more bushings 150″. The bushings150″ may be shaped and configured the same as or similar to bushings150, 150′. A cable 162 and crimp 164 connect the housing member 165″ tothe bone connecting portion 130″.

The pedicle screw shaft 137″ has a longitudinal bore (not shown) forminga cannulation that extends preferably from the tip of the screw alongthe longitudinal axis of the screw and extends into its distal end.Cable 162 extends through the cannulated screw along the longitudinalbore and extends beyond the distal end portion of the screw shaft 137″.A channel 161 extends through the housing member 165″ and is sized andconfigured to receive cable 162 there through. In use, bone connectingportion 236 may be anchored into the vertebrae or other bone with thecable 262 extending there from. The spinal rods may be inserted throughthe bushings 150″ and the housing member 165 preferably slides down thecable 262 to the bone connecting portion 130″. A crimp 164 maythereafter be inserted onto and slid along cable 162 and placed at thedesired location along the cable 162 whereby the surgeon or otheroperator may secure the crimp 164 to the cable 162 by crushing it intoposition. Securing the crimp 164 to the cable preferably secures thehousing member 165″ to the cable 162 at the desired location andpreferably fixes the housing member 165″ with respect to the boneconnecting portion 130″. The spinal rods 10 are permitted to slide andglide through bushings 160″ in guiding connector 120″ thus enablinggrowth and lengthening of the spine along a path preferably defined bythe spinal rods. The guiding connectors 120′, 120″ can be used insystems and constructs described and shown in FIGS. 1 and 3, 4 to directthe growth of the spine along a desired path.

Referring to FIGS. 10A-10C, a fifth preferred embodiment of the guidingconnector 220 for use with a spinal stabilization and guiding system isshown and described. The guiding connector 220 includes bone connectingportion 230, preferably in the form of a pedicle screw shaft 237, and aguiding portion 240. The guiding portion 240 of FIGS. 10A and 10Cincludes a platform member 265, one or more bushings 250, cable member262 and a stop member 267. In the embodiment of FIGS. 10A-10C, twobushings 252, 254 are utilized, although one bushing, or more than twobushings are contemplated. The bushings 252, 254 may be able topolyaxial rotate with respect to the platform member 265 and/or abushing housing (not shown). The bushings 252, 254 alternatively may befixed with respect to the platform member 265. The platform member 265in the embodiments of FIGS. 10A and 10C contains the two bushings 252,254, the stop member 267 and cable member 262. One end 263 of the cablemember 262 is connected to the stop member 267 and cable 262 extendsfrom the stop member 267. The platform member 265 includes a hub member266 which includes a recess 267 for receiving the top end 233 of thebone connecting portion 230. The hub 266 preferably connects theplatform member 265 to the bone connecting portion 230. The hub 266 hasa transverse passageway 269 for receipt of the cable 262 there through.

The spinal rods 10, 10′ are inserted through the bores 242, 244 locatedin the bushings 252, 254 and the cable 262 then may be wrapped aroundthe exterior of the bushing 254, through the passageway 269 in the hub266, around the bushing 252 and through a passage 268 formed in the stopmember 267 so that the second end of the cable 262 extends out of thestop member 267. Alternatively or additionally, the cable 262 may extendthrough an opening 233 formed in the bone connecting portion 230 toconnect the platform member 265 and bushings 250 to the bone connectingportion 230. The stop member 267 may incorporate a crimp mechanism orcable tie mechanism to fix and lock the position of the cable 262 withrespect to the stop member 267. A user may be able to adjust the tensionforce in the cable 262 and thus adjust the tension on the guidingconnector 220 and the compression force on the bushings 252, 254. Cable262 is locked into position to retain the bushings 250 and spinal rods10, 10′ on the guiding connector 220, preferably in a manner to positionthe bushings 252, 254 in a desired direction and orientation to permitthe spinal rod 10 to glide and slide through the guiding connector 220to correct and/or define a growth path.

In an alternative embodiment, instead of stop member 267, a crimp 264(not shown) may be applied to the end of the cable 262 and crushed andlocked into position to retain the bushings 250 on the platform member265 and the bone connecting portion 230. The embodiments of FIGS. 9 and10 have been described in connection with the use of a cable 262 andoptionally a crimp 264. It can be appreciated that a cable tie could beutilized and substituted for the cable and stop member and/or the cableand crimp.

Referring to FIG. 11 a sixth preferred embodiment of a guiding connector220′ is shown and described. The guiding connector 220′ includes boneconnecting portion 230′, preferably in the form of a pedicle screw shaft237′, and a guiding portion 240′. The bone connecting portion 230′ hasan opening 233′ formed in its top. The guiding portion 240′ comprisesthe top portion of the bone connecting portion 230′ configured to form arecess or bay 293′ to receive spinal rod 10. Bay 293′ is open at thetop. Spinal rod 10 is position in the bay 293′ and a cable tie 262′ isinserted through the opening 233′, wrapped around the spinal rod andtightened to secure the spinal rod to the bone connecting portion 230′.The bay 293′ formed in the top portion of the bone connecting portion230′ is preferably formed as a bearing element and the cable tie 262′secures the rod but permits the rod to slide relative to the bay 293′(top surface of the rod connecting portion) and the cable tie 262′.Preferably the bay 293′ and cable tie 262′ are designed and treated tominimize friction and promote sliding of the spinal rod 10.

Referring to FIGS. 12A-12D, a seventh preferred embodiment of a guidingconnector 320 for use in a guiding system for stabilizing the spine andproviding a growth path is provided. Guiding connector 320 includes abone connecting portion 330, preferably in the form of a pedicle screwshaft 337, and a guiding portion 340. Guiding portion 340 includes aplatform member 365 having wings 380 and 385, central protrusion 390 anda connecting portion 395. The connecting portion 395 connects theplatform 365 to the bone connecting portion 330. The connecting portion395 has flexible fingers 396 that preferably snap into the opening 333in the bone connection portion 330. The wings 380, 385 have an innersurface and an exterior surface and preferably are flexible and bendableand may be used to attach one or more rods 10 to the guiding connector330. The platform portion 365 (preferably the protrusion and wings) andis preferably made of plastic or other polymer material, preferably PEEKor ultra high molecular weight polyethylene (UHMWPE), to facilitatesliding and movement of the spinal rods through the wings 380, 385. Thecentral protrusion 390 is optional and preferably separates the twospinal rods and preferably provides a bearing surface to facilitaterelative sliding of the rods within the platform member 365. The wings380, 385, and/or the platform member 365 may further be composed ofmetal or metal alloy or other materials to strengthen and reinforce theplatform member 365. The bearing surfaces may further be polished orcoated with materials to promote sliding movement of the rods within andthrough the folded wings 380, 385.

In use, the rods 10 are inserted through the top opening 361 so thatthey rest in the recess or bays 393 formed between the centralprotrusion 390 and the wings 380, 385. After the rods 10 are placed inthe platform member 365 one of the wings 380, 385 is bent and flexedaround the spinal rods. Next the other wing 380, 385 is bent around thespinal rods 10 and the first wing 380, 385. A cable tie 362 isthereafter inserted through the bore 333 and extends around the exteriorsurface of the folded wings 380, 385 and tightened to secure theposition of the rods 10 relative to the guiding connector 330 so as topermit sliding motion of the spinal rods 10 relative to the guidingconnector 330. Movement of the guiding connector 320 along the spinalrod constrains the motion and growth of the vertebrae preferably along apredetermined path. To strengthen and facilitate the bending nature ofthe wings 380, 385, the wings may have ridges 398 formed along the widthof the wings 380, 385. Cable tie 362 also facilitates securing theplatform member 365 to the bone connecting portion 330.

While the guiding connector 320 has been shown and described as havingtwo (2) wings 380, 385 and one central protrusion 390 forming two (2)recess or bays 393 for two (2) spinal rods 10, 10′, it can beappreciated that the platform member may include only one wing, noprotrusions 390, and only one recess 393 for one spinal rod. Theplatform member may also be configured for more than two spinal rods,and may include two or more protrusions 390, two or more recesses 393and more than two wings.

Referring to FIGS. 13A-C, an eighth preferred embodiment of a guidingconnector 420 is shown and illustrated for use in a system forstabilizing the spine and restricting and/or facilitating growth of thespinal column 7 along a predetermined path. The guiding connector 420includes a bone connecting portion 430 preferably in the form of a screw437 having threads for anchoring in vertebral bone. Guiding connector420 further includes a guiding portion 440 attached to the boneconnecting portion 430. Guiding portion 440 includes platform member465, one or more wings 480, 485, and a central protrusion 490. Theguiding connector 420 is similar to the connector 320 described above.The platform member 465 is connected to the bone connecting portion 430in a manner that preferably provides a passageway 433 for receipt ofcable tie 462 as shown and described below.

Connecting mechanism 495 includes two support members 496, 496′extending from the bone connecting portion 430. Support members 496,496′ have bores 497, while central protrusion 490 of the platform member465 has a cavity 453 (not shown). A pin rivet or screw 499 is receivedthrough bores 497 and cavity 453 to connect wings 480, 486 to theconnecting portion 495. The pin 499 in the bores 497 and the cavity 453preferably permits the platform member 465 to rotate, swivel or pivotwith respect to the bone connecting portion 430. The bendable, flexiblewings 480, 485 may extend as shown in FIG. 13A, or alternatively couldbe curved to form recesses or bays 493, 494 for the spinal rods 10. Theguiding portion 440 may also include only one wing 480, and one centralprotrusion 490 as shown in FIG. 13B. Additional wings, protrusions andoptional recesses 493 may be provided in guiding portion 440.

In use, the spinal rods 10 are top loaded into the opening 461 with eachspinal rod 10 inserted on one side of the guiding connector 420 so thateach spinal rod 10 is located between the protrusion 490 and a wing 480,485. When the rods 10 are adjusted into their desired position, thecable tie 462 is inserted through passageway 433 and wrapped around thewings 480, 485 and tightened to secure the spinal rods 10 to the guidingconnector 420. FIG. 13C illustrates cable tie 462 passed through thepassageway 433. The embodiments illustrated in FIGS. 13A and C canaccommodate two spinal rods, while the embodiment illustrated in FIG.13B is designed to hold a single spinal rod. FIG. 13D illustrates asystem utilizing guiding connector 420′ implanted into a schematicallyrepresented spinal column. The platform member 465 preferably forms abearing member with the protrusion 490 and the wings 480, 485,preferably formed to facilitate and promote relative sliding of thespinal rods 10.

The guiding connector 320, 420, 420′ and cable tie 462 may be implantedusing an implant holder 425 as illustrated in FIG. 14. Implant holder425 includes a handle portion 426, a distal holder 427 and a proximalholder 428. The proximal holder 428 has a channel 422 and is insertedover the distal end 421 of the implant holder 425. The shaft portion 423of the implant holder 425 is inserted through the channel 422 and theproximal holder 428 is slid up the shaft 423 of the handle portion 426so that it is loaded and preferably contacting or proximate to the stopmember 429. The distal holder 427 has a channel 424 and the distal end421 of the handle portion 426 is inserted through the channel 424 andthe distal holder 427 is slid up the shaft portion 423 of the handleportion 426 so that it is proximate the proximal holder 428 previouslyloaded on the handle portion 426. The implant holder 425 with theproximal and distal holders 427, 428 proximate the stop member 429 is inthe ready position to receive and connect to the guiding connector 420and cable tie 462.

To load the guiding connector 420, 420′ and cable tie 462 on the implantholder 425, the distal end 421 of the shaft 423 of the handle portion426 is positioned proximate to the central protrusion 490, 490′ of theguiding connector 420, 420′. The cable tie 462 is inserted through thepassageway 433 prior to or after the guiding connector 420, 420′ ispositioned proximate the implant holder 425. The wings 480, 485 andcable tie 462 preferably are bent and deflected upward to a positionalong the sides of the shaft portion 423. The distal holder 427 isthereafter slid down the shaft portion 423 toward the distal end 421 ofthe handle portion 426. The ends of the cable tie 262 are insertedthrough the channel 424 of the distal holder 427 and the distal holder427 is slid further down the shaft 423 until the wings 480, 485 are alsocontained within the channel 424. The distal holder 427 may cooperatewith a notch or other retaining mechanism to retain the distal holder427 on the proximal end 421 of the handle portion 426 retaining thecable tie 462 and wings 480, 485 to the implant holder 425.

The optional proximal holder 428 is then slid down the shaft 423 towardthe distal end 421 of the handle portion 426 and the ends of the cabletie 462 are inserted through the channel 422 of the proximal holder 427to retain the cable tie ends to the handle portion 426. The cable tie462 and guiding connector 420 in this manner is loaded onto and retainedon the implant holder 425 as shown in FIG. 14 and ready for insertioninto the instrument for connecting the guiding connector 420 to thedesired bone. The guiding connector 420, 420′, cable tie 462 and implantholder 425 may be preassembled, packaged, sterilized and sold as a unit,or the component parts can be supplied separately and assembled prior toor during the surgical procedure.

The steps of inserting the guiding connector, cable tie and implantholder 425 into a driver instrument is illustrated in FIGS. 16A-16C. Thedriver facilitates providing torque to the guiding connector 420 toattach it to a vertebra. The driver 434 is preferably configured as ahollow sleeve 439 having a central cannulation and a torque transmittinginterface at its distal end. The torque transmitting interface isdesigned to interface and cooperate with a mechanism or structure on theguiding connector to transmit torque to the guiding connector.

The implant holder 425 with preassembled connector 420, 420′ and cabletie 462 as illustrated in FIG. 14 is inserted into the proximal end ofthe driver 434 and down the hollow sleeve 439 as shown in FIG. 16A untilthe distal holder 427 contacts and abuts against the proximal end of thesleeve 439. The implant holder 425 with guiding connector 420 and cabletie 462 is further inserted down the sleeve 439 so that the distalholder 427 slides proximally toward the proximal holder 428 and stopmember 429 as shown in FIG. 16B. The implant holder 425, and shaft 423,continue traveling down the sleeve 439 (with distal and proximal holders427, 428 sliding toward the stop member 429) until the guiding connector320, 420, 420′ extends out of the distal opening of the sleeve 439 asshown in FIG. 16C. The implant holder 425 may extend into sleeve 439until the stop member 429, proximal holder 427 and distal holder 428contact and abut each other as shown in FIG. 16C. Thus a smooth push onthe implant holder 425 causes the holder 425 to slide easily into thedriver 434 whereby the distal and proximal holder 427, 428 slide backautomatically.

Referring to FIGS. 17-19, a ninth preferred embodiment of a guidingconnector 520 is shown and illustrated for use in a system for guidingand stabilizing the growth of the spinal column 7 along a predeterminedpath. The guiding connector 520 includes a bone connecting portion 530,preferably in the form of a lamina clamp for attaching to the lamina ofa vertebrae. The bone connecting portion 530 includes front legs 531,531′ and back legs 534, 534′ that are preferably adjustable by adjustingmechanism 532, which may include a screw element 533. Rotation of screwelement 533 preferably adjusts the separation of front leg 531 fromfront leg 531′, and adjusts the relative separation of back leg 534 fromback leg 534′. Screw element 533 preferably also adjusts the relativeseparation of the front legs 531, 531′ from the back legs 534, 534′.

Guiding connector 520 further includes a guiding portion 540 whichincludes an integral lateral rod-connecting member 545. Bone connectingportion 530 may have one or more sleeve elements 537 to receive one ormore lateral rod connecting members 545. Lateral rod connecting members545 are preferably laterally adjustable and securable to sleeve elements537. A set screw (not shown) may permit adjustment and locking of thelateral rod connecting member 545 relative to the sleeve element 537.The lateral rod connecting member 545 adjusts the distance the spinalrods may be positioned relative to the spinal column and may be used topull the spinal rods closer to the bone connecting portion or push thebone connecting portion further away.

The lateral rod connecting member 545 as shown in FIG. 19 may include ahousing 565 which may contain one or more bushing elements 550. Thebushings 550 preferably have a frusto-spherical outer surface andpreferably can polyaxially rotate in housing 565. Alternatively, thebushings 550 may be fixed relative to housing 565. The bushing 550contains a bore 542 through which spinal rods 10 may be received. Thespinal rods 10, 10′ preferably can move with respect to the bushing 550when implanted within a patient.

Referring to FIG. 20, a tenth embodiment of a guiding connector 620 isshown. Guiding connector 620 includes the guiding portion 640 of theembodiment of FIGS. 17 and 19 (including the lateral rod connectingmember 545). Bone connecting portion 630 includes two (2) side loadingpedicle screws 15′ (which may be monoaxial, monorotational, orpolyaxial) arranged to receive lateral connecting portion 645 so thatlateral rod connecting portion 645 extends transverse to the axis of thespinal column 7.

Lateral rod connecting offset connectors such as those illustrated inFIGS. 17-20 may be particularly useful where there is a severe curvatureof the spine, such as, for example, where the implanted spinal rods areunable to extend along the vertebrae of the spinal column.

Referring to FIGS. 21 and 22 an eleventh embodiment of a guidingconnector is shown which includes a lateral offset connector. Guidingconnector 720 includes a bone connecting portion 730, which in theembodiments of FIGS. 21 and 22 preferably is a screw 737, and a guidingportion 740. Guiding portion 740 includes a lateral connector 765 whichhas two rod receiving bores 742 which are configured to receive spinalrods 10, 10′ and permit, facilitate and promote movement of rods 10, 10′relative to lateral connector 765. The lateral connector 765 has afurther port 763 for receiving a connector 775 for attaching the lateralconnector 765 to the bone connecting portion 730. In the embodiment ofFIGS. 21 and 22 the connector 775 preferably is a cable tie 762. Theconnector 775 preferably is relatively stiff to provide support to rods10, 10′.

The port 763 is preferably configured to accept the connector 775 from aproximal or distal side so that lateral connector 765 can be attached tobone connecting portion 730 in both configurations shown in FIGS. 21 and22. In the construct of FIG. 21, the port 763 is arranged to be closestto the bone connecting portion 730 such that the connector 775 does notextend or wrap around the spinal rods 10, whereas in FIG. 22 the port763 is arranged in the construct to be distal to the bone connectingportion 730 such that the connector 775 extends and wraps substantiallyaround the lateral connector 765 and spinal rods 10, 10′ which mayprovide more support to the spinal rods 10, 10′. The tension in thecable tie 762 can be adjusted by the user and can be used to pull thespinal rods closer to the bone connecting portion 730 preferably to helpstraighten the spinal column.

Referring to FIG. 23 an twelfth embodiment of a guiding connector in theform of a parallel connector is shown. The guiding connector 820 has aguiding portion 840 but no bone connecting portion. The guiding portion840 has a housing 865 that includes a hook portion 867 that preferablyis fixedly secured to spinal rod 10 with a set screw. The set screw isoptional and may be eliminated such that spinal rod 10 may move relativeto housing 865. The housing 865 also includes a bushing 850, preferablya bushing 850 that can polyaxial rotate relative to the housing 865. Thebushing 850 has a bore 842 to receive spinal rod 10′ there through.Spinal rod 10′ preferably can translate and slide through bushing 850 ina direction relatively parallel to the axis of spinal rod 10.

Referring to FIG. 24, a thirteenth embodiment of a guiding connector inthe form of an alternative parallel connector is shown. The guidingconnector 920 has a guiding portion 940 but no bone connecting portion.The guiding portion 940 has a housing 965 that preferably has one ormore bores 942 preferably configured as bearing elements to receivespinal rods 10, 10′. In the parallel connector 920 the housing has twobores 942 to receive spinal rods 10, 10′. Preferably the spinal rods 10,10′ can translate and slide through bores 942. One or more set screws(not shown) may be provided to lock the position of either spinal rod10, 10′. One or more openings 961 which extend into the bores 942 may beprovided to permit side loading of the spinal rods 10, 10′. The openings961 are preferably smaller than the diameter of the spinal rods so thatthe spinal rods can be snapped into the bores 942 and be retained in thehousing 965. A channel 983 may be formed substantially around the sideof the parallel connector 920 to receive a securing strap, such as, forexample a cable tie. The securing strap 962 may secure spinal rods 10,10′ in bores 942 while permitting the rods to translate and slide insitu when the system is implanted in a patient. The parallel connectorspreferably promote keeping the spinal rods parallel and from contactingeach other to promote and encourage ease of sliding and the telescopicaction.

As will be appreciated by those of skill in the art, any or all of thecomponents described herein may be provided in sets or kits so that thesurgeon may select various combinations of components to perform astability procedure and create a system which is configured specificallyfor the particular needs and anatomy of a patient. It should be notedthat one or more of each component may be provided in a kit or set. Insome kits and sets, the same device may be provided in multiplequantities, and in different shapes and/or sizes.

The stabilization and guiding system is preferably provided to the userin a kit that may include (1) one or more elongated support members suchas, for example, spinal rods; (2) one or more bone anchors for fixedsecuring the elongated support members to a bone (for example, avertebrae) preferably to form one or more anchor points; (3) one or moreguiding connectors with bone connecting portions and mechanisms; (4) oneor more lateral connectors; and (5) one or more parallel connectors.

The guiding connectors may be preassembled and include one or moresecuring elements such as cable ties, straps or cables. The guidingconnectors may be preassembled and loaded onto or into an implant holderand/or a driving instrument. The guiding connectors and spinal rods maybe made from any biocompatible material now known or hereafterdiscovered including, but not limited to, metals, such as, for example,titanium, titanium alloy, stainless steel, cobalt chromium, Nitinol,etc. Other materials, such as, for example, plastics, polymers,composites, ceramics and any other material now know or later discoveredalso may be used for the guiding connectors and spinal rods. The rodsand the guiding connectors, or portions thereof can be polished and orcoated with material to facilitate and promote the relative motion ofthe spinal rods relative to the guiding connectors.

While the foregoing description and drawings represent the preferredembodiments of the present invention, it will be understood that variousadditions, modifications, combinations and/or substitutions may be madetherein without departing from the broad spirit and scope of the presentinvention as defined in the accompanying claims. In particular, it willbe clear to those skilled in the art that the present invention is notlimited to the particular embodiments shown and described but may beembodied in other specific forms, structures, arrangements, proportions,and with other elements, materials, features and components, withoutdeparting from the spirit or essential characteristics of the invention.One skilled in the art will appreciate that the invention may be usedwith many modifications of structure, arrangement, proportions,materials, features, and components and otherwise, used in the practiceof the invention, which are particularly adapted to specificenvironments and operative requirements without departing from theprinciples of the present invention. In addition, features describedherein may be used singularly or in combination with other features. Thepresently disclosed embodiments are, therefore, to be considered in allrespects as illustrative and not restrictive, with the scope of theinvention being indicated by the appended claims and not limited to theforegoing description.

1. A system to stabilize and guide the growth of the spinal column, the system comprising: at least one elongated support member having a width and a length; at least one guiding connector having a bone connecting portion and a guiding portion, the bone connecting portion configured and adapted to firmly secure the guiding connector to a vertebrae and the guiding portion having a bearing element having at least one passageway configured and adapted to receive the elongated support member wherein the bearing element permits relative sliding movement of the elongated support element in the passageway of the bearing element; and at least one bone fixation element having an elongated support member receiving channel, a locking mechanism and a bone anchoring portion, the bone anchoring portion configured and adapted to firmly secure the bone fixation element to bone to provide a firm anchoring point, and the locking mechanism configured and adapted to firmly secure the elongated support member in the channel, wherein the guiding connector is configured to be moveable along the elongated support member to permit and control the growth of the spinal column along a predetermined path.
 2. The system of claim 1 wherein the bone connecting portion of the guiding connector comprises at least one of the group of hooks, pins, tacks, stakes, nails, blades, screws and clamps.
 3. The system of claim I wherein the bearing element has a front face, a back face, sides, a plurality of the passageways extending through the bearing element from the front face to the back face, and a housing surrounding the sides of the bearing element and connecting the bearing element to the bone connecting portion, wherein an interior surface defines the passageways and is formed of a polymer material.
 4. The system of claim 1 wherein the guiding connector comprises a platform member, at least one bushing, a clamp member and a securing mechanism, wherein the bushing has the at least one passageway and has an outer side surface, the platform member and clamp member surround at least a portion of the side surface of the bushing, and the securing mechanism has an unlocked position that permits the bushing to polyaxial rotate with respect to the platform member and the clamp member and a locked position which fixes the position of the bushing with respect to the platform member and the clamp member.
 5. The system of claim 4 wherein the guiding connector has two bushings, each bushing having a frusta-spherically-shaped outer side surface and the securing mechanism comprises a threaded set screw.
 6. The system of claim 1 wherein the bone connecting portion comprises a post member and the guiding portion comprises: at least one sleeve connector having a hollow sleeve defining a bore and a recess for receiving the post member, the sleeve connector fitted over the post member; a bushing forming the bearing element positioned within the bore of the sleeve and polyaxially rotatable with respect to the sleeve; and a nut configured to fit onto and connect with the post member to fix the position of the sleeve connector and the bushing, wherein the elongated support element is slideable within the passageway of the bearing element when the bushing is fixed with respect to the sleeve.
 7. The system of claim 6 wherein the sleeve connector comprises a C-shaped clamp having a first leg and a second leg, and wherein the nut compresses the first leg into the second leg to fix the position of the bushing relative to the sleeve while permitting the rod to slide relative to the bushing.
 8. The system of claim 6 wherein the bushing is formed from a polymer material and the sleeve is formed of a material different than the bushing.
 9. The system of claim 1 wherein the guiding connector comprises: a housing member having at least one opening which receives at least one bushing and a channel extending through the housing member at an angle relative to the opening, the bushing having the passageway for receiving the elongated support member; a cable extending from the bone connecting portion and through the channel in the housing; and a crimp securable to the cable to connect the housing member to the bone connecting portion, wherein the elongated support member is slideable within the bushing when the guiding connector is implanted.
 10. The system of claim 1 wherein the guiding portion further comprises: a platform member and at least one bushing, the bushing mounted on the platform member, and a cable member having first and second ends, wherein the cable member extends at least partially around the bushings and secures the bushing on the platform member and to the bone connecting portion.
 11. The system of claim 10 wherein the guiding portion further comprises a stop member wherein the cable extends out of the stop member and wraps around at least a portion of the bushing and the cable is adjustably fixedly securable to the stop member to adjust the tension in the cable.
 12. The system of claim 1 wherein the bone connecting portion further comprises a transverse opening and the guiding portion further comprises a platform member having at least one flexible wing having an inner surface and an outer surface, and a connecting portion for attaching the platform member to the to the bone connecting portion, wherein the at least one wing is bendable around the elongated support member to form at least a portion of the bearing element, and wherein the guiding connector further comprises a cable, wherein the cable is configured to extend around the outer surface of the at least one wing and through the opening to secure the elongated support member in the bearing element formed by the at least one wing.
 13. The system of claim 1 wherein the guiding portion further comprises a platform member having at least one flexible wing having an inner surface and an outer surface, and a connecting portion for pivotally attaching the platform member to the bone connecting portion, wherein the at least one wing is bendable around the at least one elongated support member to form at least a portion of the bearing element, and wherein the guiding connector further comprises a cable, wherein the cable extends around the outer surface of the at least one wing to secure the at least one elongated support member in the bearing element formable by the at least one wing.
 14. The system of claim 13 wherein the platform member further comprises a protrusion member and at least two flexible wings wherein the protrusion member and wings form at least two bays for receipt of two elongated support members, the protrusion and wings constituting at least a portion of the bearing element for the elongated support members.
 15. The system of claim 13 further comprising a guiding connector holder comprising: a handle portion having a shaft having a distal end and a proximal end, the proximal end having a stop member; a distal holder having a channel; and a proximal holder having a channel, wherein the channel of the proximal holder is insertable over the distal end of the handle portion and slideable relative to the shaft and is configurable to secure the cable tie to the handle portion, and the channel of the distal holder is insertable over the distal end of the handle portion and slideable relative to the shaft and is configurable to secure the at least one wing of the guiding connector and cable tie to the handle portion.
 16. The system of claim 1 further comprising a lateral rod connecting member having the guiding portion integrally and monolithically formed with the lateral rod connecting portion, wherein the lateral rod connecting member is adjustably securable to the bone connecting portion to adjust the position of the guiding portion with respect to the spinal column.
 17. The system of claim 1 further comprising a parallel connector, the parallel connector having a housing comprising a hook for securely and optionally fixedly receiving at least one of the elongated support members, and an opening for receipt of a bushing, the bushing having a bore for slideably receiving at least one of the elongated support members and permitting in-situ movement of that elongated support member.
 18. The system of claim 1 further comprising a parallel connector and a cable, the parallel connector having a housing having two bores, two openings, and exterior sides, each opening extending from an exterior side of the housing into the interior of the bores, the bores sized to slideably receive the elongated support member and the openings sized smaller than the width of the elongated support member to facilitate securing of the elongated support members within the bores, the housing being flexible to permit the elongated support members to pass through the openings and into the bores, the housing further having a channel in the exterior side and extending around at least a portion of the bores for receiving the cable, whereby the cable is receivable in the channel to secure the elongated support members within the bores and permit sliding motion of the elongated support members with respect to the housing. 